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NCT00720798 · OUTCOME

Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264

An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies · Source last updated 2014-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline to Week 264

What was measured

Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" \[symptom-free and no arthritis symptoms\], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.

Analysis population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.

Groups in this outcome

Tocilizumab

Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Tocilizumab2067

Reported measurements

ACR20 Week 24 (n=1966)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab59.5Not reportedNot reportedNot reportedNot reported
ACR20 Week 48 (n=1825)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab66.7Not reportedNot reportedNot reportedNot reported
ACR20 Week 108 (n=1607)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab74.1Not reportedNot reportedNot reportedNot reported
ACR20 Week 156 (n=1512)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab74.3Not reportedNot reportedNot reportedNot reported
ACR20 Week 204 (n=1415)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab77.5Not reportedNot reportedNot reportedNot reported
ACR20 Week 264 (n = 1319)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab78.7Not reportedNot reportedNot reportedNot reported
ACR50 Week 24 (n=1966)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab34.9Not reportedNot reportedNot reportedNot reported
ACR50 Week 48 (n=1825)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab44.4Not reportedNot reportedNot reportedNot reported
ACR50 Week 108 (n=1607)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab52.8Not reportedNot reportedNot reportedNot reported
ACR50 Week 156 (n=1512)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab54.7Not reportedNot reportedNot reportedNot reported
ACR50 Week 204 (n=1415)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab56.5Not reportedNot reportedNot reportedNot reported
ACR50 Week 264 (n= 1319)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab58.8Not reportedNot reportedNot reportedNot reported
ACR70 Week 24 (n=1966)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab17.8Not reportedNot reportedNot reportedNot reported
ACR70 Week 48 (n=1825)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab25.5Not reportedNot reportedNot reportedNot reported
ACR70 Week 108 (n=1607)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab33.2Not reportedNot reportedNot reportedNot reported
ACR70 Week 156 (n=1512)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab35.7Not reportedNot reportedNot reportedNot reported
ACR70 Week 204 (n =1415)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab38.6Not reportedNot reportedNot reportedNot reported
ACR70 Week 264 (n=1319)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab40.5Not reportedNot reportedNot reportedNot reported
ACR90 Week 24 (n=1966)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab4.3Not reportedNot reportedNot reportedNot reported
ACR90 Week 48 (n=1825
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab7.9Not reportedNot reportedNot reportedNot reported
ACR90 Week 108 (n=1607)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab12.1Not reportedNot reportedNot reportedNot reported
ACR90 Week 156 (n=1512)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab14.7Not reportedNot reportedNot reportedNot reported
ACR90 Week 204 (n=1415)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab17.7Not reportedNot reportedNot reportedNot reported
ACR90 Week 264 (n=1319)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab18.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59.5
    title
    ACR20 Week 24 (n=1966)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        66.7
    title
    ACR20 Week 48 (n=1825)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        74.1
    title
    ACR20 Week 108 (n=1607)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        74.3
    title
    ACR20 Week 156 (n=1512)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        77.5
    title
    ACR20 Week 204 (n=1415)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        78.7
    title
    ACR20 Week 264 (n = 1319)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        34.9
    title
    ACR50 Week 24 (n=1966)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        44.4
    title
    ACR50 Week 48 (n=1825)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        52.8
    title
    ACR50 Week 108 (n=1607)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        54.7
    title
    ACR50 Week 156 (n=1512)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        56.5
    title
    ACR50 Week 204 (n=1415)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        58.8
    title
    ACR50 Week 264 (n= 1319)
denoms
  1. counts
    1. group Id
      OG000
      value
      2067
    units
    Participants
description
Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" \[symptom-free and no arthritis symptoms\], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
groups
  1. description
    Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    id
    OG000
    title
    Tocilizumab
param Type
NUMBER
population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
time Frame
Baseline to Week 264
title
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice